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Last Updated: November 12, 2019

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AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - Generic Drug Details

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What are the generic sources for amlodipine besylate; atorvastatin calcium and what is the scope of freedom to operate?

Amlodipine besylate; atorvastatin calcium is the generic ingredient in two branded drugs marketed by Dr Reddys, Mylan, Zydus Pharms, and Pfizer, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are fifty drug master file entries for amlodipine besylate; atorvastatin calcium. Six suppliers are listed for this compound.

Recent Clinical Trials for AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Haining Health-Coming Biotech Co., Ltd.Phase 2
Dr. Reddy's Laboratories LimitedPhase 1

See all AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM clinical trials

Recent Litigation for AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

Identify potential future generic entrants

District Court Litigation
Case NameDate
Edwards Lifesciences AG v. CoreValve, Inc.2014-04-14
Pfizer Inc. v. Dr. Reddy's Laboratories Ltd.2012-04-13
Pfizer Inc. v. Sandoz Inc.2010-02-09

See all AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM litigation

Paragraph IV (Patent) Challenges for AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Tradename Dosage Ingredient NDA Submissiondate
CADUET TABLET;ORAL amlodipine besylate; atorvastatin calcium 021540 2009-09-17
CADUET TABLET;ORAL amlodipine besylate; atorvastatin calcium 021540 2009-04-07
CADUET TABLET;ORAL amlodipine besylate; atorvastatin calcium 021540 2006-12-29

US Patents and Regulatory Information for AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate; atorvastatin calcium TABLET;ORAL 203874-009 Mar 7, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Pfizer CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-008 Jan 30, 2004 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Dr Reddys AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate; atorvastatin calcium TABLET;ORAL 203874-011 Mar 7, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-009 Jul 29, 2004   Start Trial   Start Trial
Pfizer CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-005 Jan 30, 2004   Start Trial   Start Trial
Pfizer CADUET amlodipine besylate; atorvastatin calcium TABLET;ORAL 021540-004 Jan 30, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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